An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761154
Company: MYLAN PHARMS INC

Medication Guide

Products on BLA 761154

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HULIO	ADALIMUMAB-FKJP	20MG;0.4ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761154

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/06/2020	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761154s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761154Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761154Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761154Orig1s008ltr.pdf
08/25/2023	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761154Orig1s005ltr.pdf
03/03/2023	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761154orig1s003ltr.pdf
07/14/2022	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761154s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761154Orig1s002ltr.pdf

Labels for BLA 761154

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154Orig1s008lbl.pdf
12/15/2023	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154Orig1s008lbl.pdf
12/15/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154Orig1s008lbl.pdf
08/25/2023	SUPPL-5	Bioequivalence	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154s005lbl.pdf
03/03/2023	SUPPL-3		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154s003lbl.pdf
07/14/2022	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761154s002lbl.pdf
07/06/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761154s000lbl.pdf

Top